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KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

C

Catholic University (KU) of Leuven

Status and phase

Completed
Phase 2

Conditions

Critical Illness

Treatments

Drug: intensive insulin therapy to maintain normoglycemia

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00115479
S18630
KULeuven OT/03/56
FWO grant number G.0278.03

Details and patient eligibility

About

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Full description

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults admitted to ICU and anticipated to require intensive care for at least a few days

Exclusion criteria

  • Expected short ICU stay
  • Therapy restricted upon admission
  • Surgical ICU patients
  • Other studies
  • Below 18 years
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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